Study to Evaluate the Safety, Tolerability,Immunogenicity, and Pharmacokinetics of MEDI-528 in Healthy Adult Volunteers

This study has been completed.

Sponsor:

MedImmune LLC

ClinicalTrials.gov Identifier:

NCT00192296

First Posted: September 19, 2005

Last Update Posted: March 6, 2014

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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Time to Observed Maximum Serum Concentration (Tmax) [ Time Frame: Days 0 (prior to and after the end of the infusion, and at 1, 2, 4, 8, and 12 hours after the end of the infusion), 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84 ]

Tmax of MEDI-528

Observed Maximum Serum Concentration (Cmax) [ Time Frame: Days 0 (prior to and after the end of the infusion, and at 1, 2, 4, 8, and 12 hours after the end of the infusion), 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84 ]

Cmax of MEDI-528

Area Under the Concentration Curve From Time Zero to Last Measurable Concentration [AUC(0-t)] [ Time Frame: Days 0 (prior to and after the end of the infusion, and at 1, 2, 4, 8, and 12 hours after the end of the infusion), 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84 ]

AUC(0-t) of MEDI-528

Area Under the Concentration Curve From Time Zero to Infinity [AUC(0-infinity)] [ Time Frame: Days 0 (prior to and after the end of the infusion, and at 1, 2, 4, 8, and 12 hours after the end of the infusion), 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84 ]

AUC(0-infinity) of MEDI-528

Percent of Total Area Under the Concentration Curve Extrapolated From Last Measurable Time to Infinity [AUC(Ext)] [ Time Frame: Days 0 (prior to and after the end of the infusion, and at 1, 2, 4, 8, and 12 hours after the end of the infusion), 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84 ]

The primary objective of this Phase I study is to evaluate the safety and tolerability of escalating single IV doses of MEDI-528 administered to healthy adult volunteers.

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:

18 Years to 49 Years (Adult)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria:

Males and females age 18 up to and including 49 years of age at the time of the first dose of study drug

Weight < 89 kg

Written informed consent obtained from the volunteer

Healthy by medical history and physical examination

Sexually active females, unless surgically sterile or at least one year post-menopausal, must use an effective method of avoiding pregnancy (including oral, injectable, transdermal or implanted contraceptives, IUD, female condom, diaphragm with spermicide, cervical cap,abstinence, use of a condom by the sexual partner or sterile sexual partner) for 3 months before the first dose of study drug, and must agree to continue using such precautions through 84 days after their dose of study drug. Cessation of birth control after this point should be discussed with a responsible physician. Sexually active males, unless surgically sterile, must likewise use an effective method of birth control (condom or abstinence) and must agree to continue using such precautions through 84 days after their dose of study drug.

Use of common over-the-counter medications such as topical corticosteroids, decongestants, antihistamines, analgesics, and antacids is permitted unless, in the opinion of the investigator, it would interfere with either the volunteer's ability to complete the study or interpretation of study results.

Ability to complete the follow-up period of 84 days

Willing to forego other forms of experimental treatment during the study period of 84 days

Exclusion Criteria:

Acute illnesses or evidence of significant active infection, such as fever ≥38.0°C (100.5°F) at the start of the study

Use of prescription medications, other than contraceptives, in the 28-day period before Study Day 0

Blood donation in excess of 400 mL within 6 months of the time of entry into the study

History of use of tobacco products within 3 years of Study Day 0 or history of smoking of >10 pack-years

History of immunodeficiency or receipt or current use of immunosuppressive drugs including systemic corticosteroids

History of allergic disease or reactions likely to be exacerbated by any component of the Study Drug (described in the Investigator's Brochure)

History of substance abuse that, in the opinion of the investigator, may compromise the ability of the study subject to complete the study and follow-up period

Evidence of any systemic disease on physical examination

Evidence of infection with hepatitis A, B, or C virus or HIV-1

Receipt of immunoglobulins or blood products within 60 days of entering the study

Receipt of any investigational drug therapy within 60 days of the first dose of study drug through Study Day 84 (use of licensed agents for indications not listed in the package insert is permitted)